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Chemotherapy-induced Peripheral NeuropathyCIPN-LEANCT05759052

Vincristine-induced Peripheral Neuropathy in Adult Survivors of Childhood and Adolescent Leukemia

An observational study of Chemotherapy-induced Peripheral Neuropathy, run by University Hospital, Clermont-Ferrand at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Vincristine is a major anticancer agent in the management of hematological malignancies. One of the main side effects is chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a characteristic side effect of neurotoxic anticancer drugs. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
self-administered questionnaire
How many people
467 participants
Where
1 siteFrance
Study dates
12 May 2023to 4 Nov 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients will be enrolled from the French Childhood Cancer Survivor Study For Leukaemia (LEA Cohort), in each particiapting centers

Who may be able to join

  • adult patient (> 18-year) who received a vincristine-based chemotherapy for hematological malignancy in childhood

Who cannot join

  • Secondary cancer (leukemia and/or cancer)
  • Active oncological pathology
  • Current cancer treatment
  • Adults protected

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU Clermont-Ferrand

    Clermont-Ferrand

Other trials in France

About this study

Official title: Long-term Evaluation of Vincristine-induced Peripheral Neuropathy in Adult Survivors of a Multicenter Prospective Cohort of Childhood and Adolescent Leukemia (LEA Cohort): a Multicenter Cross-sectional Study

Vincristine is a major anticancer agent in the management of hematological malignancies. One of the main side effects is chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a characteristic side effect of neurotoxic anticancer drugs. CIPN associated with vincristine is typically characterized by distal and symmetrical sensory symptoms (dysesthesia and paresthesia). Motor and vegetative symptoms can also be found. The prevalence of CIPN associated with vincristine during treatment ranges from 12 to 100% in children (depending on the endpoint).

The aim of this cross-sectionnal study will be to explore the CIPN prevalence and severity in adult survivors of childhood leukemia and having been treated by vincristine.

Read the detailed description

Adult survivors of chidlhood leukemia and having been treated by vincristine will be contacted from the French childhood cancer survivor study for leukaemia (LEA Cohort) in order to seek their participation agreement.

Thereafter patients will received a self-administered questionnaire exploring the chemotherapy-induced peripheral neuropathy and related comorbidities (pain, neuropathic pain, anxiety, depression, health-related quality of life, substance use, physical activity, deprivation). Oncological and sociodemographic characteristics of participants will be recorded.

Being tested
self-administered questionnaire
Keywords
vincristine-induced peripheral neuropathy, pediatric leukemia, cancer survivor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • self-administered questionnaireBehavioural

    Patients will answer to a self- administered questionnaire exploring chemotherapy-induced peripheral neuropathy and related comorbidities

Study groups in NCT05759052
Study groupRoleWhat they receive
Cohort of adult survivors having been treated by vincristineCohort of adult survivors having been treated by vincristine for a childhood leukemia
Receives: Behavioral: self-administered questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensitive chemotherapy-induced peripheral neuropathy

    Scores of the sensitive subscale of the QLQ-CIPN20 questionnaire (quality of life questionnaire - chemotherapy-induced peripheral neuropathy 20 questions) scores : 0 least - 100 worst

    Measured: day 1

Secondary outcomes (16)

  1. Motor chemotherapy-induced peripheral neuropathy

    Scores of the motor subscale of the QLQ-CIPN20 questionnaire (quality of life questionnaire - chemotherapy-induced peripheral neuropathy 20 questions) scores : 0 least - 100 worst

    Measured: day 1

  2. Pain severity

    Scores of pain severirty assessed with a visual analogic scale scores : 0 no pain - 10 maximal pain

    Measured: day 1

  3. Neuropathic pain

    Scores of the DN4 interview questionnaire (Douleur neuropathique 4 questions) Scores : 0 least - 7 worst Threshold for neuropathic pain : 3

    Measured: day 1

  4. Ongoing analgesic treatment

    Reporting of ongoing analgesic treatment declared by the patient

    Measured: day 1

  5. Anxiety severity

    Scores of the anxiety subscale of the HADS questionnaire (Hospital anxiety and depression scale) Anxiety scores: 0 least - 21 worst Normal scores: ≤7 Borderline or suggestive of possible anxiety: 8-10 Indicative of anxiety: ≥11

    Measured: day 1

  6. Depression severity

    Scores of the depression subscale of the HADS questionnaire (Hospital anxiety and depression scale) Depression scores: 0 least - 21 worst Normal scores: ≤7 Borderline or suggestive of possible depression: 8-10 Indicative of depression: ≥11

    Measured: day 1

  7. Health-related quality of life

    Scores of the SF36 questionnaire (short-form 36) for each item: 0 worst - 100 best

    Measured: day 1

  8. Physical activity and sedentarity

    GPAQ questionnaire (Global Physical Activity Questionnaire) Work-related physical activity (minutes) Leisure-related physical activity (minutes) Time spent sitting (minutes)

    Measured: day 1

  9. Deprivation

    Scores of the EPICES questionnaire (Evaluation de la Précarité et des Inégalités de santé dans les Centres d'Examens de Santé) Scores: 0 best - 100 worst

    Measured: day 1

  10. Use of legal and illegal psychoactive drugs

    Reporting of legal psychoactive drug use (alcohol, tobacco, e-cigarette, psychoactive medication, cannabidiol, and other), and illegal psychoactive drug use (cannabis, and other)

    Measured: day 1

  11. Oncological characteristics

    Type of hematological malignancy and date of diagnosis ; Chemotherapy received: vincristine (date of last course and cumulative dose), anthracyclines (cumulative dose) ; Radiation therapy received: central nervous system irradiation and total dose, total body irradiation and total dose ; Hematopoietic stem cell (HSC) transplant: autograft or allograft, and date of transplant(s) ; Relapse (date)

    Measured: day 1

  12. Oncological characteristics

    Type of hematological malignancy, date of diagnosis, and relapse (date)

    Measured: day 1

  13. Anticancer drugs received

    vincristine (date of last course and cumulative dose), and anthracyclines (cumulative dose)

    Measured: day 1

  14. Radiation therapy received

    Central nervous system irradiation (total dose), total body irradiation (total dose)

    Measured: day 1

  15. Hematopoietic stem cell transplant

    Autograft or allograft, and date of transplant(s)

    Measured: day 1

  16. Sociodemographic characteristics

    Age at the time of the response to the study questionnaire ; Age at diagnosis of hematological malignancy ; Gender ; Weight, height, body surface area, weight-for-age and sex-percentile at diagnosis ; Weight, height and BMI at time of response ; Intercurrent pathology at time of response ; socio-professional group

    Measured: day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2023
  2. Study start12 May 2023
  3. Primary completion4 Nov 2025
  4. Study completion4 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
467 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05759052
Sponsor's protocol ID
PHRC IR 2021 BALAYSSAC
Other IDs
2022-A01758-35
Acronym
CIPN-LEA
Status last verified
Dec 2025
First submitted
13 Feb 2023
Last updated
24 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chemotherapy-induced Peripheral Neuropathy, run by University Hospital, Clermont-Ferrand at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitive chemotherapy-induced peripheral neuropathy (time frame: day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05759052.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.

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